BioSpace Collaborative

Academic/Biomedical Research
News & Jobs
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  C2C Services & Suppliers™
Europe
Asia

DIVERSITY

PROFILES
Company Profiles

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Research Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
Get Our Industry eNewsletter FREE email:    
   

Eisai Inc. (ESALF.PK) Granted Additional Six Month U.S. Marketing Exclusivity for ACIPHEX® (Rabeprazole Sodium)


12/11/2012 9:44:36 AM

WOODCLIFF LAKE, N.J., Dec. 11, 2012 /PRNewswire/ -- Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) determined that Eisai has met the FDA's Written Request requirements for pediatric exclusivity for ACIPHEX® (rabreprazole sodium). As a result, Eisai has now gained an additional 6 months of United States market exclusivity for ACIPHEX, which will expire on November 8, 2013.

(Logo: http://photos.prnewswire.com/prnh/20120413/MM87168LOGO )

The granting of pediatric exclusivity does not mean that ACIPHEX is approved for use in pediatric patients. Eisai has a New Drug Application (NDA) pending before the FDA for ACIPHEX Delayed-Release Sprinkle Capsules 5mg and 10mg for the proposed indication of healing of Gastroesophageal Reflux Disease (GERD), maintenance of healing of GERD and improvement of symptoms of GERD in children 1 to 11 years of age. The FDA assigned a Prescription Drug User Fee Act (PDUFA) date of March 27, 2013.

Indications for currently approved ACIPHEX 20mg:
In adults (greater than or equal to 18 years of age), one ACIPHEX 20mg tablet daily is used for the treatment of daytime and nighttime heartburn and other symptoms associated with acid reflux disease. ACIPHEX is also used for the short-term (4 to 8 weeks) treatment in the healing and symptom relief of damaging (erosive) acid reflux disease (gastroesophageal reflux disease) and to maintain healing of damage (erosion) and relief of heartburn symptoms that happen with acid reflux disease. ACIPHEX has not been studied for treatment lasting longer than 12 months (1 year).

In adolescents (greater than or equal to 12 years of age), one ACIPHEX 20mg tablet daily is used for the treatment of daytime and nighttime heartburn and other symptoms associated with acid reflux disease.

Important Safety Information about ACIPHEX 20mg:

  • Symptom relief does not rule out other serious stomach conditions.
  • Serious allergic reactions may occur. Tell your doctor if you have a rash, face swelling, throat tightness, or difficulty breathing.
  • Proton Pump Inhibitor (PPI) medicines may increase your risk of getting severe diarrhea. This diarrhea may be caused by an infection (Clostridium difficile) in your intestines. If you have watery stool, stomach pain, and fever that does not go away, call your doctor immediately.
  • People who are taking multiple daily doses of PPI medicines for a long period of time may have an increased risk of fractures of the hip, wrist, or spine.
  • Low magnesium can happen in some people who take a PPI medicine for at least 3 months. Tell your doctor right away if you experience any of these symptoms: seizures, dizziness, abnormal or fast heartbeat, jitteriness, jerking movements or shaking (tremors), muscle weakness, spasms of the hands and feet, cramps or muscle aches, or spasm of the voice box.
  • In adolescents, the most common side effects with ACIPHEX include headache, diarrhea, nausea, vomiting, and abdominal pain.
  • In adults, the most common side effects of ACIPHEX include pain, sore throat, gas, infection, and constipation.
  • Before taking ACIPHEX, tell your doctor if you are taking any of these medicines: atazanavir, digoxin, iron salts, ketoconazole, warfarin, or methotrexate.

For more information about ACIPHEX (rabeprazole sodium), see full Prescribing Information or go to www.ACIPHEX.com.

About Eisai Inc.
Eisai Inc. was established in 1995 and began marketing its first product in the United States in 1997. Since that time, Eisai Inc. has rapidly grown to become a fully integrated pharmaceutical business. The company serves as the U.S. pharmaceutical operation of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world.

Eisai has a global product creation organization that includes U.S.-based R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania, as well as manufacturing facilities in Maryland and North Carolina. The company's areas of R&D focus include neuroscience; oncology; vascular, inflammatory and immunological reaction; and antibody-based programs. For more information about Eisai, please visit www.eisai.com/US.

CONTACT:




Media Inquiries

Investor Inquiries

Marcia J. Diljak

Alex Scott

Eisai Inc.

Eisai Inc.

201-746-2236

201-746-2177

SOURCE Eisai Inc.


Read at BioSpace.com


   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES
 

//-->